Compliance Training

<body topmargin=0 leftmargin=0 marginheight=0 marginwidth=0> <table cellpadding=0 cellspacing=0 border=0><tr> <td valign="top" rowspan="2" width=150 BGCOLOR="#FFFFFF" TEXT="#080000"> <bR> <bR> <bR> <bR> <bR> <bR> <div> <A HREF="id53.htm" TARGET="_top" TITLE="Validation Compliance Services"><U>Validation & Compliance Services</U></A></div> <div> <B>Compliance Training</B></div> <div> <A HREF="id54.htm" TARGET="_top" TITLE="Project Management"><U>Project Management</U></A></div> </td> <td valign="top" colspan=2 height=95 BGCOLOR="#FFFFFF" TEXT="#080000"> <div> <FONT SIZE="5" COLOR="#FFFFFF" FACE="BrushScript BT" ><B>Skrip</B></FONT><FONT SIZE="2" COLOR="#FFFFFF" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="5" COLOR="#FFFFFF" FACE="Trebuchet MS" > </FONT><FONT SIZE="5" COLOR="#FFFFFF" FACE="Arial" >Partners.</FONT>    <A HREF="index.htm" TARGET="_top" TITLE="SkripTek Partners, Inc."><U>home</U></A><FONT SIZE="5" COLOR="#FFFFFF" FACE="Arial" >, In        </FONT><B> </B><B> </B></div> <div> <I><B>"Productivity and Compliance are NO LONGER mutually exclusive."</B></I></div> <bR> <div> <A HREF="id17.htm" TARGET="_top" TITLE="About Us"><U>About Us</U></A>   ·   <A HREF="id19.htm" TARGET="_top" TITLE="Contact Us"><U>Contact Us</U></A>   ·   <A HREF="id39.htm" TARGET="_top" TITLE="Information Request"><U>Information Request</U></A>   ·   <A HREF="id31.htm" TARGET="_top" TITLE="Premium Partners"><U>Premium Partners</U></A>   ·   <A HREF="id20.htm" TARGET="_top" TITLE="Products"><U>Products</U></A>   ·   <A HREF="id49.htm" TARGET="_top" TITLE="Services"><U>Services</U></A>       </div> <bR> <bR> <bR> <bR> <bR> <bR> <div> </div> </td> </tr><tr> <td valign="top" height=385 colspan=2 BGCOLOR="#FFFFFF" TEXT="#080000"> <bR> <div> <I>Compliance Training</I></div> <div> <B>Skrip</B><FONT SIZE="1" COLOR="#990000" FACE="Comic Sans MS" ><B>Tek</B></FONT><FONT SIZE="1" COLOR="#000066" FACE="Arial" > </FONT><FONT SIZE="1" COLOR="#000066" FACE="Verdana" >can provide an entire spectrum of validation training. Our professionals can deliver our standard courses or develop a course specific to your needs. Many clients find our One-day Validation Overview to be an excellent refresher course, or a great validation Project Kick-off activity to ensure an understanding of the project purpose and to introduce team members to a common validation language.</FONT></div> <bR> <div> <B>Validation Project Kick-off Training</B></div> <bR> <div> This dedication to life-long learning extends an on-site, introductory Computer Validation and Part 11 training session. Thousands of individuals within the Pharmaceutical and Medical Device Manufacturing industries have benefited from this nationally-recognized training session on compliance and regulatory issues.</div> <bR> <div> Why not kick-off your next validation project with our full-day session covering Computer Validation and 21 CFR Part 11. Have your team all speaking the same language, and understanding what and why they are working on this project. Assemble 5-25 of your compliance and regulatory personnel for this content-rich validation training. </div> <bR> <div> Here is a sample of your training day:</div> <bR> <div> <I><B>9 a.m. - 12:00 p.m. - Formal Training Session</B></I></div> <div> • Background</div> <div> • Regulatory Requirements - Part 11 & Computer Validation</div> <div> • Regulatory Activity and Changes - 483's and Warning Letters</div> <div> • Part 11 Compliance Strategy</div> <bR> <div> <I><B>12:00 p.m. - 1:00 p.m. - Lunch Break</B></I></div> <bR> <div> <I><B>1:00 p.m. - 3:00 p.m. - Q & A Period (optional)</B></I></div> <div> • Breakout Discussion on Specific Part 11 Compliance</div> <div> Questions</div> <bR> <div> This Q & A Period becomes company specific. Why not take advantage of having recognized, industry leaders under your roof to discuss the particular challenges you face? You'll learn why achieving Part 11 compliance to date has not been easy, how you can learn from 483's and Warning Letters, and how good validation practices can benefit your organization (improve producctivity) by meeting deadlines and rolling out systems that satisfy user needs.</div> <bR> <div> Your staff will obtain a greater understanding of the impact of Part 11 and the documentation required.</div> <bR> <div> You'll develop an increased awareness of current FDA enforcement activities as well as a clearer understanding of the recent changes. Attendees will receive a 21 CFR Part 11 and Computer Validation training certificate, a copy of the training slides, an assessment checklist, and a versatile laminated 21 CFR Part 11 tip sheet.</div> <bR> <div> If these structured classes don't address your specific concerns regarding computer validation, Part 11, and GXPs, we'd be glad to craft a customized session around the challenges you face. We'd discuss your company's operations to specifically determine your requirements. We'd then recommend a program directed to those particular needs.</div> <bR> <div> Thousands have profited from the validation and regulatory know-how of our seasoned trainers. The response has been gratifying. QA Edge truly enjoys addressing the critical nature of validation and how technology constantly changes the flow of the market.</div> <bR> <div> <B>Validation Boot Camp</B></div> <bR> <div> Validation Boot Camp is not designed for the feeble or fainthearted. This intensive, five-day, educationally charged session covers validation of software and 21 CFR Part 11 from “soup to nuts”.</div> <div> This in-depth course covers the entire process of software validation including: Introduction to Part 11 Compliance, Validation Preparation, Validation Planning & Design, Testing, and Validation Completion.</div> <div> Complete computer validation training, from beginning to advanced concepts, is offered in this rigorous course. It's also designed for a more advanced audience - delving deeper, explaining the process for completing deliverables.</div> <div> During the class exercises, you'll be introduced to <I>Solution11 XL</I><I>TM </I>an innovative software tool that guarantees spreadsheet compliance for your Part 11 initiatives. Simple to operate, it ensures the integrity of Excel files with a complete audit trail, logging each saved action.</div> <div> The flexibility and focus of this training session and its supporting materials can be customized to more closely meet your specific organizational requirements. Scheduling can also be segmented allowing the 5-day training to be delivered around your schedule.</div> <div> Allow us to draft an agenda that will specifically meet your regulatory and scheduling requirements.</div> <bR> <div> <B>Deliverables</B></div> <bR> <div> Attendees will receive:</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Manuals and electronic copies of all slides,</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Complete set of validation SOPs</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Templates for URS, Validation Plan, Design Review Memo, Test Plan, Test Script, Traceability Matrix, Technical Specification, Validation Report, Revalidation Form, System Audit Report, and</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Reference Manuals</div> <bR> <div> <B>cGMP and ISO Quality Management Systems Development Classes</B></div> <bR> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Process Mapping (Course and Workshop) </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Process Mapping Techniques </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Internal Quality Auditing  </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">Internal Quality Auditing for Executives </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR for Executives</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR for Middle Management  </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR for Hourly Employees </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR (Course and Workshop) </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR vs. ISO 13485:2003  </div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">cGMP-QSR vs. ISO 13485:2003</div> <div> <IMG BORDER="0" SRC="Symb075c00b700b466000000.png" HEIGHT="12" WIDTH="24" ALIGN="bottom" HSPACE="0" VSPACE="0">ISO 9001:2000 (Course and Workshop) </div> <bR> <bR> </td> </tr></table></body>